Phase Ia Pharmacokinetic and Tolerability Study of Oral NV-27 in Normal Healthy Volunteers

Phase 1

Completed

• Conditions: Safety and tolerability of the investigational drug NV-27 in healthy male volunteers; Other - Research that is not of generic health relevance and not applicable to specific health categories listed above

• Registration Number: ACTRN12607000611426
• Lead Sponsor: ovogen Research Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-11-28
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 6

Inclusion Criteria

a) Normal healthy male volunteers
b) At screening, patients must have all clinical pathology analytes within the laboratory’s reference ranges
c) Participants must be 18 - 40 years of age
d) Non-smokers
e) Participants must be able to understand the risks and benefits of the study and give written informed consent to participation

Exclusion Criteria

a) Participants who are on a concurrent investigational drug study or who have had any treatment with any investigational agents within 4 weeks of commencing the study
b) Alcohol consumption of > 40g per day
c) A history of alcohol or drug dependence within the last three years
d) A chronic illness which requires regular therapy
e) Asthma
f) Previous hypersensitivity or allergy to aspirin or other anti-inflammatory agents
g) Use of any prescription medication within the preceding week

Study & Design

• Study Type: Interventional
• Study Design: Not specified